According to an analysis, the US FDA issued complete response letters (CRLs) to six novel drugs seeking first approval approvals during the first quarter of 2023. These CRLs highlight the stringent requirements for efficacy and safety data that the FDA demands before granting market access to new pharmaceuticals.
Eli Lilly’s Donanemab and Other Drugs Face Rejection
Among the products that received CRLs was Eli Lilly’s Alzheimer’s disease therapy, donanemab. The FDA’s CRL, issued in January, noted that only a limited number of patients—approximately 100—who had received the drug treatment for at least 12 months in the trials used to support donanemab’s marketing were considered insufficient for full approval.
Soligenix’s SGX301 and Cytokinetics’ Omecamtiv Microcarbil Also Rejected
In February 2023, the FDA refused to accept Soligenix’s NDA filing for SGX301 in cutaneous T-cell lymphoma (CTCL), deeming the NDA incomplete and unable to undergo a full review. Additionally, Cytokinetics faced rejection for its filing for omecamtiv microcarbil, a potential treatment for heart failure with reduced ejection fraction (HFrEF). The FDA stated that the GALACTIC-HF study, which formed the basis of the NDA application, lacked sufficient persuasiveness to demonstrate the drug’s effectiveness in reducing heart failure events and cardiovascular death risk, necessitating additional substantial evidence.
Veru’s Sabizabulin and Other Applications Denied or Requested for More Information
In March, the emergency use authorization (EUA) application for Veru’s sabizabulin was rejected. The drug, intended for high-risk, moderate-to-severe COVID-19 patients with acute respiratory distress syndrome (ARDS), achieved its goal of reducing mortality in small-scale trials but faced uncertainty regarding its efficacy. Furthermore, the FDA requested additional information for marketing applications for AbbVie’s ABBV-951 (foslevodopa/foscarbidopa) and Incyte’s ruxolitinib sustained-release tablets, citing uncertainty about efficacy and safety as the main reason for the request.-Fineline Info & Tech
